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Summary Background Mesalazine (mesalamine) granules (MG) were shown to be effective for the maintenance of remission of ulcerative colitis (UC) in two double-blind placebo-controlled trials. Aim To evaluate the efficacy of once-daily MG for maintenance of remission in patients with UC who switched from other 5-aminosalicylic acid (5-ASA) formulations. Methods Data from two independent multicenter, randomised, double-blind, placebo-controlled, 6-month trials evaluating patients with UC in remission were combined for analysis of a subpopulation of patients who switched from other 5-ASA formulations to MG 1.5 g or placebo upon randomisation. The primary endpoint was the percentage of patients who remained relapse-free at Month 6 or end of treatment. Relapse was defined as a Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, a UC flare or medication used to treat a UC flare. Results Of the 487 patients who received 5-ASA maintenance therapy at enrolment, 322 were in the MG group and 165 were in the placebo group. The percentage of patients who remained relapse-free (based on Sutherland Disease Activity Index scores) after 6 months was significantly higher with MG than placebo (78.3% vs. 58.8%, P

Aliment Pharmacol Ther 2010; 32: 990–999 Summary Background Ulcerative colitis (UC) is a chronic relapsing and remitting idiopathic inflammatory bowel disorder. Aim To evaluate once-daily mesalamine (mesalazine) granules (MG) for maintenance of remission of UC. Methods Randomized, double-blind, placebo-controlled trial of patients (n = 209 MG, n = 96 placebo) with UC in remission [revised Sutherland Disease Activity Index (SDAI) rectal bleeding = 0, mucosal appearance

Background The risk of postpolypectomy bleeding (PPB) in patients undergoing colonoscopy on uninterrupted clopidogrel therapy has not been established. Objective To assess the PPB rate and outcome and identify risk factors associated with PPB in patients taking clopidogrel. Design Single-center, retrospective study. Demographics, clinical parameters, polyp characteristics, polypectomy techniques, and postpolypectomy events in the groups were compared by univariate analysis. Stepwise logistic regression analyses identified independent risk factors associated with PPB. Setting Veterans Affairs Medical Center. Patients A total of 142 patients (375 polypectomies) taking clopidogrel (cases) and 1243 patients (3226 polypectomies) not taking clopidogrel (controls). Interventions None. Main Outcome Measurements Postpolypectomy bleeding, hospitalization, and mortality. Results The immediate (intraprocedural) bleeding rate was similar in the 2 groups (2.1% vs 2.1%). Delayed (postprocedural) PPB rate was higher in the group taking clopidogrel (3.5% vs 1.0%, P = .02). Delayed bleeding of significance requiring hospitalization and transfusion/intervention was also higher in patients taking clopidogrel (2.1% vs 0.4%, P = .04). The length of hospital stay and interventions for PPB were comparable between the 2 groups. There was no mortality. Concomitant use of clopidogrel and aspirin/other nonsteroidal anti-inflammatory drugs (odds ratio 3.7; 95% CI, 1.6-8.5) and the number of polyps removed (OR 1.3; 95% CI, 1.2-1.4) were the only significant risk factors associated with PPB. Clopidogrel alone was not an independent risk factor for PPB. Limitations Retrospective study and small number of patients with PPB. Conclusions The PPB rate is significantly higher in patients undergoing polypectomy while taking clopidogrel and concomitant aspirin/nonsteroidal anti-inflammatory drugs; however, the risk is small and the outcome is favorable. Routine cessation of clopidogrel in patients before colonoscopy/polypectomy is not necessary.

BACKGROUND: Aspirin, by virtue of inhibition of platelet hemostatic function, is withheld before many invasive procedures because of the bleeding risk. American Society of Gastrointestinal Endoscopy guidelines acknowledge the paucity of “high quality data” to make recommendations regarding the use of aspirin (ASA) and nonsteroidal anti-inflammatory drugs (NSAIDs) before endoscopic procedures. Yet the majority of endoscopists hold ASA/NSAIDs before polypectomy. METHODS: This single-center, retrospective, cohort study was conducted at Veterans Affairs Medical Center, Syracuse, NY. The objectives were to assess the postpolypectomy bleeding risk in ASA/NSAID users in a large cohort of veterans undergoing colonoscopic polypectomy and to identify risk factors associated with postpolypectomy bleeding. All patients undergoing polypectomy between January 2002 and October 2007 were eligible. Patients on anticoagulants/other antiplatelet agents were excluded. Patients were selected randomly by cluster sampling techniques. Electronic medical and pharmacy records were reviewed for patient demographics, polypectomy techniques, and postpolypectomy bleeding rates. Univariate analysis was performed between patients on ASA and NSAIDs (group A) versus those not on ASA or NSAIDs (group B). Multiple regression analysis was performed to identify independent risk factors associated with postpolypectomy bleeding. RESULTS: Five hundred two (43%) of 1174 patients (mean age 66 years, 92% white) were on ASA or NSAIDs, or both. There was no significant difference between postpolypectomy bleeding rates among the 2 groups (3.2% vs 3.0%). Age, sex, polyp characteristics, and polypectomy techniques were comparable between groups A and B. In multiple logistic regression analysis, ASA or NSAID use was not a significant risk factor for postpolypectomy bleeding. Number of polyps removed per patient was the only risk factor significantly associated with postpolypectomy bleeding (P .01, odds ratio 1.3, 95% confidence interval, 1.18-1.43). CONCLUSIONS: In this large study, use of ASA or NSAIDs did not increase the risk of postpolypectomy bleeding. Cessation of ASA/NSAIDs before colonoscopy/polypectomy is therefore unnecessary. Published by Elsevier Inc. • The American Journal of Medicine (2012) 125, 1222-1227